FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical
company, and its subsidiary FibroGen China Medical Technology
Development Co., Ltd. (FibroGen China), today announced that the
China Food and Drug Administration (CFDA) has accepted the
company’s recently submitted New Drug Application for registration
of roxadustat (FG-4592 or
罗沙司他), a novel oral
investigational treatment for anemia in dialysis-dependent CKD
(DD-CKD) and non-dialysis-dependent CKD (NDD-CKD) patients. Under
the terms of FibroGen’s agreement with AstraZeneca, the NDA
submission triggers a $15 million milestone payment, payable to
FibroGen by AstraZeneca.
“This is an important milestone for FibroGen and for roxadustat.
We look forward to working with the CFDA on this important new drug
registration application process,” said Thomas B. Neff, FibroGen’s
Chief Executive Officer. “In China, there is a significant need for
a new therapeutic for patients with anemia associated with CKD, a
serious and potentially life-threatening condition.”
“We are grateful for the opportunity to address a substantial
unmet medical need for the treatment of anemia associated with CKD
in China, where the CKD dialysis population is growing rapidly and
large segments of the CKD non-dialysis population are not reached
by current therapies,” said Chris Chung, FibroGen’s Vice President
of China Operations. “If approved, roxadustat will be the first
HIF-PHI available worldwide, with China as the first approval
country for this first-in-class drug.”
The New Drug Application for roxadustat is based on the results
of FibroGen’s two Phase 3 multi-center, randomized, controlled
studies conducted in China, one study in CKD dialysis comparing
roxadustat against a branded epoetin alfa, and one study in CKD
non-dialysis comparing roxadustat against placebo. Both of
the Phase 3 studies met their primary efficacy endpoints with no
new or unexpected safety signals identified.
About Anemia Associated with CKD in China
Anemia commonly develops in association with chronic kidney disease
and is linked to significant morbidity and mortality in both the
dialysis and non-dialysis populations. CKD affects an estimated
119.5 million patients in China. Although CKD may occur at any
age, it is more common in aging populations, and its prevalence is
increasing. CKD can be both a cause and a consequence of
cardiovascular disease and is a critical healthcare issue. With the
exception of kidney transplantation, there is no treatment
available that is curative, or has the ability to stop kidney
deterioration.
The dialysis population in China, which exceeds 400,000
patients, has been growing at a double-digit rate. The number of
patients that require anemia therapy in China and other emerging
markets is expected to increase steadily, as the CKD population
continues to grow and the number of hemodialysis and peritoneal
dialysis patients increases. There is a significant opportunity for
roxadustat to treat patients on dialysis (hemodialysis and
peritoneal dialysis) and not on dialysis, as well as to address
need in the large number of patients whose anemia remains
undertreated or untreated in China.
About Roxadustat Roxadustat (FG-4592) is a
first-in-class, orally administered small molecule in global Phase
3 clinical development worldwide as a therapy for anemia associated
with chronic kidney disease (CKD) with the potential to offer a
safer, more effective, more convenient, and more accessible
treatment than the current therapies available for anemia in CKD,
such as injectable erythropoiesis stimulating agents (ESAs).
Roxadustat promotes erythropoiesis through increasing endogenous
erythropoietin, improving iron regulation, and reducing hepcidin.
Administration of roxadustat has been shown to induce coordinated
erythropoiesis – increasing red blood cell count while maintaining
plasma erythropoietin levels within or near normal physiologic
range in multiple subpopulations of CKD patients – including in the
presence of inflammation and without a need for supplemental
intravenous iron.
FibroGen, along with collaboration partners Astellas Pharma Inc.
and AstraZeneca AB, has designed a Phase 3 program to support
regulatory approval of roxadustat for both NDD-CKD and DD-CKD
patients worldwide. To date, this is the largest Phase 3 clinical
program in anemia, enrolling more than 10,000 subjects worldwide.
FibroGen anticipates filing a U.S. New Drug Application (NDA) for
roxadustat for the treatment of anemia associated with CKD in
2018.
FibroGen and its partner AstraZeneca are collaborating on the
development and commercialization of roxadustat in the U.S., China,
and other markets. In China, FibroGen China is conducting all
clinical trials and will hold all roxadustat regulatory licenses
and permits to be issued by China regulatory authorities. After
market approval, FibroGen China will manage manufacturing and
medical affairs and AstraZeneca will manage launch and
commercialization activities in China. FibroGen and Astellas are
collaborating for the development and commercialization of
roxadustat in Europe, Japan, the Commonwealth of Independent
States, the Middle East, and South Africa.
In the next stage of its development program, roxadustat is
entering a Phase 2/3 clinical trial in China and a Phase 3 clinical
trial in the U.S. for the treatment of anemia in patients with
myelodysplastic syndromes (MDS).
For information about roxadustat studies currently recruiting
patients, please visit clinicaltrials.gov at:
https://clinicaltrials.gov/ct2/results?term=FG-4592&Search=Search
About FibroGen, Inc. FibroGen, Inc.,
headquartered in San Francisco, CA with subsidiary offices in
Beijing and Shanghai, PRC, is a leading science-based
biopharmaceutical company discovering and developing a pipeline of
first-in-class therapeutics. The company applies its
pioneering expertise in hypoxia-inducible factor (HIF) and
connective tissue growth factor (CTGF) biology and clinical
development to advance innovative medicines for the treatment of
anemia, and fibrotic disease and cancer. Roxadustat, the company’s
most advanced product candidate, is an oral small molecule
inhibitor of HIF prolyl hydroxylase activity in worldwide Phase 3
clinical development for the treatment of anemia in chronic kidney
disease (CKD) with the exception of China, where a new drug
application is currently under review by the CFDA for regulatory
approval. Roxadustat is also entering Phase 3 development for
anemia in myelodysplastic syndromes (MDS). Pamrevlumab, a
fully-human monoclonal antibody, that inhibits the activity CTGF,
is in Phase 2 clinical development for the treatment of
idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and
Duchenne muscular dystrophy (DMD). FibroGen is also developing a
biosynthetic cornea in China. For more information, please visit
www.fibrogen.com.
Forward-Looking Statements This release
contains forward-looking statements regarding our strategy, future
plans and prospects, including statements regarding the development
of the company's product candidate roxadustat in China, the
potential safety and efficacy profile of roxadustat and its
potential to treat patients, including in anemia associated with
myelodysplastic syndromes, and our clinical plans, including timing
for planned initiation of clinical trials in China and the U.S.
These forward-looking statements include, but are not limited to,
statements about our plans, objectives, representations and
contentions and are not historical facts and typically are
identified by use of terms such as “may,” “should,” “could,”
“expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“potential,” “continue” and similar words, although some
forward-looking statements are expressed differently. Our actual
results may differ materially from those indicated in these
forward-looking statements due to risks and uncertainties related
to the continued progress and timing of our various programs,
including the enrollment and results from ongoing and potential
future clinical trials for pamrevlumab, and other matters that are
described in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2016, and our Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2017 and June 30, 2017, respectively,
filed with the Securities and Exchange Commission (SEC), including
the risk factors set forth therein. Investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this release, and we undertake no
obligation to update any forward-looking statement in this press
release, except as required by law.
ContactFibroGen, Inc.Karen L. BergmanVice
President, Investor Relations and Corporate Communications1 (415)
978-1433kbergman@fibrogen.com
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